K-15 PORK 71425323Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556733042), received between May 15, 2025 and May 15, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K211221, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, AFTER A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, ON (B)(6) 2025, 17 DAYS POSTOPERATIVELY, THE PATIENT BEGAN OUTPATIENT PHYSICAL THERAPY, AND DURING HOME THERAPY PERIOD, A FALL WAS REPORTED. ON A FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT REPORTED PERSISTENT KNEE PAIN, WHICH INCREASED WITH MOVEMENT. THE PATIENT REPORTED THAT AFTER EXPERIENCING A TWISTING INJURY TO THE KNEE SHORTLY AFTER SURGERY, HAD NOT FULLY RECOVERED. RADIOGRAPHIES SHOWED A PERIPROSTHETIC MEDIAL PROXIMAL TIBIA FRACTURE LEADING TO GROSS LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 IN WHICH THE TIBIAL COMPONENT WAS REVISED DURING THE PROCEDURE. PATIENT'S CURRENT STATUS IS NORMAL RECOVERY OF REVISION PROCEDURE.

  Patient problems: Fall; Inadequate Osseointegration; Periprosthetic fracture

  MAUDE report 22024944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211221, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint